Prevention Ambassadors: Intervention to Promote HIV Service Engagement in the Networks of SSP Clients

Prevention Ambassadors: an HIV Self-testing Intervention to Promote HIV Service Engagement in the Networks of SSP Clients

HIV testing and service uptake are infrequent among people who use drugs (PWUD) in the United States. In partnership with a community-based syringe service program (SSP), this project will develop the SSP-based "Prevention Ambassadors" (PA) intervention to promote HIV testing and service uptake among PWUD via the secondary distribution (i.e., peer delivery) of HIV self-testing (HIVST) kits with local HIV service information and referrals to HIV service navigation in the social networks of SSP clients (i.e., PWUD). The PA intervention will then be piloted to assess its preliminary effects, acceptability, and feasibility among PWUD in the Ending the HIV Epidemic priority jurisdiction of Riverside County, California.

Study Overview

• Status: Recruiting
• Conditions: HIV
• Intervention / Treatment: Behavioral: Prevention Ambassadors; Behavioral: SSP Standard of Care

• Study Type: Interventional
• Enrollment (Estimated): 210
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heather Pines; Phone Number: 619-594-2481; Email: hpines@sdsu.edu

Study Locations

• United States
  • California
    • San Diego, California, United States, 92182
      • Recruiting
      • San Diego State University
      • Contact: Heather Pines; Phone Number: 619-594-2481; Email: hpines@sdsu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Index Participant Inclusion Criteria:

• Being greater than or equal to 18 years old
• Reporting drug use (past month)
• Having other people who use drugs (PWUD) in one's social network
• Being willing to talk about HIV testing and services with at least 2 PWUD in their networks and attempt to refer them to the study
• Speaking English fluently

Peer-Recruit Participant Inclusion Criteria:

• Being greater than or equal to 18 years old
• Reporting drug use (past 3 months)
• Being recruited by an index participant (evidenced by presenting the coupon used to recruit them)
• Speaking English fluently

Exclusion Criteria:

- Persons who participated in formative study activities related to the development of the PA intervention will not be eligible to participate.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prevention Ambassadors	Behavioral: Prevention Ambassadors; Delivery of prevention supplies and information on local services plus training to build the capacity of PWUD to distribute HIV self-testing (HIVST) kits with information and referrals to other PWUD in their social networks to promote HIV testing and HIV service engagement among PWUD.
Other: SSP Standard of Care	Behavioral: SSP Standard of Care; Delivery of prevention supplies and information on local services.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HIV testing (past 3 months)	Self-reported via survey and abstracted from medical record	3-month follow-up
Linkage to PrEP/HIV care (past 3 months)	Self-reported via survey and abstracted from medical record	3-month follow-up
PrEP/ART uptake (past 3 months)	Self-reported via survey and abstracted from medical record	3-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PA Acceptability (Peer-Recruit Participants)	Self-reported via survey	Baseline
PA Acceptability (Index Participants)	Self-reported via survey	3-month follow-up
PA Feasibility (Peer-Recruit Participants)	Self-reported via survey	Baseline
PA Feasibility (Index Participants)	Self-reported via survey	3-month follow-up

Collaborators and Investigators

• Sponsor: San Diego State University
• Collaborators: National Institute on Drug Abuse (NIDA); University of California, San Diego; University of California, Riverside; Dap Health
• Investigators: Principal Investigator: Heather A Pines, San Diego State University; Principal Investigator: Angela R Bazzi, University of California, San Diego

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: February 18, 2025
• First Submitted That Met QC Criteria: February 21, 2025
• First Posted (Actual): February 27, 2025

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: HS-2023-0051; R34DA058389 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data will be made available upon review of written requests from researchers.
• IPD Sharing Time Frame: Approximately 6 months after the publication of the study's primary findings.
• IPD Sharing Access Criteria: Requests from researchers for de-identified data will be reviewed by the research team (Multiple Principal Investigators and Co-Investigators).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No